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Carbon 450 H

by Baxter Medical Systems GmbH + Co. KG

Ref 2077584

Carbon 450 H (2077584) is a device classified as Class I in the EU and Class II in the US made by Baxter Medical Systems GmbH + Co. KG, registered in EUDAMED on 30 Mar 2026 (Basic UDI-DI 0887761GMN000010TP) and listed in FDA GUDID since 14 Dec 2022 (UDI-DI 00887761967410), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0887761GMN000010TP Basic UDI-DI 00887761967410UDI-DIDate30 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887761967410 UDI-DI Date14 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0887761GMN000010TP registered 30 Mar 2026 Active
  • FDA GUDID UDI-DI 00887761967410 listed 14 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00887761967410
  2. Registered EUDAMED 0887761GMN000010TP

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Carbon 450 H EUDAMED
Carbon Sections GUDID
Generic name
Operating table orthopaedic extension, non-powered
Model / reference
2077584
Primary DI / UDI-DI
00887761967410
Basic UDI-DI
0887761GMN000010TP
FDA product code
KXJ, JEA, GDC
EMDN code
Z12011280 Patient positioning instruments - hardware accessories
GMDN term
Operating table orthopaedic extension, non-powered
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1980, 878.4960
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
DE-MF-000005071

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES.

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Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)